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临床试验/NCT03921593
NCT03921593Unknown不适用

Prospective Longitudinal Observational Study on Insulin Dependent Diabetic Patients Undergoing Any Form of Solid Organ Pancreas Transplantation Aimed to Clarify Quality of Life Changes After Pancreas Transplantation

University of Oxford1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2018年11月4日最近更新:
适应症

试验速览

阶段
不适用
入组人数
110
试验地点
1
主要终点
Quantification of Quality of Life

研究概览

简要总结

Quality of Life for individuals with Insulin Dependent Diabetes Mellitus (IDDM) can be severely impaired by acute and chronic complications of the disease.

Solid organ pancreatic transplantation restores endocrine pancreatic function. However, it is also burdened by high perioperative morbidity and mortality.

Clinical benefits and risks of this intervention have been extensively clarified, but our knowledge about quality of life gain, often mentioned among the assets of transplantation, is still limited.

This study aims to quantify the impact of all forms of Solid Organ Pancreas Transplantation on quality of life (QOL).

详细描述

Rationale of the study:

There are 3.5 million people in the United Kingdom diagnosed with diabetes. Their life expectancy is significantly reduced when compared to non-diabetic population. The long standing poor metabolic control causes a cluster of complications such as metabolic instability, cardiovascular disease, nephropathy, retinopathy and neuropathy which have a major impact on the clinical and social wellbeing of these individuals.

Solid organ pancreatic transplantation restores endocrine pancreatic function, but it is still burdened by significant perioperative morbidity and mortality.

There are other less invasive transplant options we can offer to this cohort of patients. The most common are Kidney Transplant Alone (KTA) from deceased or living donor in the diabetic and uremic patients and Islets Transplant (IT) for those with hypoglycemia unawareness and preserved renal function.

Although current literature suggests that the less invasive approaches may be less effective in the long term, potentially they could resolve the most compelling clinical needs at a lower surgical risk.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Willing and able to give informed consent for participation in the study
  • Insulin Dependent Diabetic Patients
  • Active on Pancreas Transplant Wait List

排除标准

  • Not fluent in English

结局指标

主要结局

Quantification of Quality of Life

时间窗: pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation

Completion of Short Form 12 v.2 questionnaire (SF-12 v.2®) includes 8 domains and 12 items that form two Components: Physical Health Component (PCS) and Mental Health Component (MCS) A computer-based scoring algorithm is used to calculate scores: Physical Component Summary (PCS) and Mental (MCS) Component Summary scales are generated using norm-based methods. Scores are transformed to have a mean value of 50, standard deviation (SD) 10, where scores above or below 50 are above or below average physical or mental well-being, respectively.

次要结局

  • Estimate cost-effectiveness of pancreas transplantation(pre- transplant, 1 year)
  • Correlation between clinical status and quality of life pre-transplantation(pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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